U.S. patent application number 17/734602 was filed with the patent office on 2022-08-18 for system and method for writing into the memory of an active medical device implantable by telemetry.
This patent application is currently assigned to SORIN CRM SAS. The applicant listed for this patent is SORIN CRM SAS. Invention is credited to Laure Hery, Thierry Legay.
Application Number | 20220257120 17/734602 |
Document ID | / |
Family ID | 1000006303788 |
Filed Date | 2022-08-18 |
United States Patent
Application |
20220257120 |
Kind Code |
A1 |
Legay; Thierry ; et
al. |
August 18, 2022 |
SYSTEM AND METHOD FOR WRITING INTO THE MEMORY OF AN ACTIVE MEDICAL
DEVICE IMPLANTABLE BY TELEMETRY
Abstract
A communication system for enabling a writing operation in a
memory of an implantable medical device. The communication system
includes an intermediate proximity device configured to receive
writing data transmitted by a main writing device, the intermediate
proximity device configured to communicate with the implantable
medical device. The system also includes a first external unlocking
tool configured to transmit a detectable signal when the first
external unlocking tool is located within a predetermined perimeter
of the implantable medical device, where the intermediate proximity
device is configured to cause the implantable medical device to
write the writing data into the memory of the implantable medical
device when the first external unlocking tool is in the
predetermined perimeter of the implantable medical device.
Inventors: |
Legay; Thierry; (Fontenay
Les Briis, FR) ; Hery; Laure; (Maixe, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SORIN CRM SAS |
Clamart |
|
FR |
|
|
Assignee: |
SORIN CRM SAS
Clamart
FR
|
Family ID: |
1000006303788 |
Appl. No.: |
17/734602 |
Filed: |
May 2, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16709728 |
Dec 10, 2019 |
11344198 |
|
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17734602 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2560/045 20130101;
A61N 1/37223 20130101; A61B 2562/0257 20130101; A61N 1/37252
20130101; A61B 5/0031 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61N 1/372 20060101 A61N001/372 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 11, 2018 |
FR |
1872671 |
Claims
1. A communication system for enabling a writing operation in a
memory of an implantable medical device, the communication system
comprising: an intermediate proximity device configured to receive
writing data transmitted by a main writing device, the intermediate
proximity device configured to communicate with the implantable
medical device; and a first external unlocking tool configured to
transmit a detectable signal when the first external unlocking tool
is located within a predetermined perimeter of the implantable
medical device, wherein the intermediate proximity device is
configured to cause the implantable medical device to write the
writing data into the memory of the implantable medical device when
the first external unlocking tool is in the predetermined perimeter
of the implantable medical device.
2. The communication system of claim 1, wherein the intermediate
proximity device is configured to cause the implantable medical
device to write the writing data into the memory of the implantable
medical device in response to a detection of the first external
unlocking tool in the predetermined perimeter by the implantable
medical device.
3. The communication system of claim 1, further comprising a second
unlocking tool configured to allow radio frequency communication
between the implantable medical device and the intermediate
proximity device when the intermediate proximity device has
identified the second unlocking tool so that the intermediate
proximity device is configured to write the writing data into the
memory of the implantable medical device in response to
identification of the second unlocking tool by the intermediate
proximity device.
4. The communication system of claim 3, wherein the second
unlocking tool comprises at least one password entered on the
intermediate proximity device, a biometric input received by the
intermediate proximity device, a magnetic card read via the
intermediate proximity device, a short distance wireless
communication which emits a detectable signal via a proximity
sensor of the intermediate proximity device, a magnetic field
detected by the intermediate proximity device or a transmission
received via a peripheral port of the intermediate proximity
device, in particular a USB port.
5. The communication system of claim 1, wherein the intermediate
proximity device is configured to provide at least one of a visual,
audible, or vibrating signal indicating that the writing operation
has to be performed.
6. The communication system of claim 1, wherein the intermediate
proximity device is further configured to store the writing data
transmitted by the main writing device at least until the writing
operation is activated.
7. The communication system of claim 1, wherein the first external
unlocking tool is a permanent magnet or an electromagnet whose
static magnetic field is detected by a proximity sensor of the
implantable medical device.
8. The communication system of claim 1, wherein the intermediate
proximity device is a smartphone, a digital tablet, a connected
portable device, a computer, a home medical equipment device, or a
home automation system.
9. A method for enabling a writing operation in a memory of an
implantable medical device comprising: receiving, via an
intermediate proximity device, a request for the writing operation
of the implantable medical device from a main writing device;
receiving, via the intermediate proximity device, writing data from
the main writing device; communicating, via the intermediate
proximity device, with the implantable medical device; and causing,
via the intermediate proximity device, writing of the writing data
into the memory of the implantable medical device when a first
external unlocking tool is located within a predetermined perimeter
of the implantable medical device.
10. The method of claim 9, wherein communicating, via the
intermediate proximity device, with the implantable medical device,
includes establishing a radio frequency communication between the
intermediate proximity device and the implantable medical device in
response to the first external unlocking tool being detected within
the predetermined perimeter of the implantable medical device.
11. The method of claim 9, wherein the writing operation in the
memory of the implantable medical device is prevented when a
distance between the first external unlocking tool and the
implantable medical device is greater than 15 centimeters, more
particularly greater than 10 centimeters.
12. The method of claim 9, further comprising receiving, via the
intermediate proximity device, a request to authorize radio
frequency communication between the intermediate proximity device
and the implantable medical device by a second unlocking tool.
13. The method of claim 12, wherein the second unlocking tool
comprises at least one of a password entered on the intermediate
proximity device, a biometric input received on the intermediate
proximity device, a magnetic card read by the intermediate
proximity device, a short distance wireless communication which
transmits a detectable signal via a proximity sensor of the
intermediate proximity device, a magnetic field detected by the
intermediate proximity device, or a transmission received via a
peripheral port of the intermediate proximity device, in particular
a USB port.
14. The method of claim 9, wherein radio frequency communication
between the implantable medical device and the intermediate
proximity device is realized when there is a distance of less than
10 meters between the implantable medical device and the
intermediate proximity device.
15. The method of claim 9, wherein the first external unlocking
tool emits a signal to the implantable medical device that comes
from an electromagnetic field or a static magnetic field or an
inductive field.
16. The method of claim 9, wherein the request for the writing
operation is signaled by the intermediate proximity device, which
emits at least one of a visual, audible, or vibrating signal
indicating that the writing operation has to be performed.
17. The method of claim 9, wherein the writing data is stored by
the intermediate proximity device at least until authorization of
radiofrequency communication between the intermediate proximity
device and the implantable medical device.
18. One or more non-transitory computer-readable storage media
having instructions stored thereon that, upon execution by one or
more processors, cause the one or more processors to perform
operations comprising: receiving writing data from a main writing
device; communicating with the implantable medical device; and
causing a writing of the writing data into the memory of the
implantable medical device, responsive to detecting a first
external unlocking tool within a predetermined perimeter of the
implantable medical device by the implantable medical device.
19. The one or more non-transitory computer-readable storage media
of claim 18, wherein communicating with the implantable medical
device includes establishing a radio frequency communication with
the implantable medical device in response to the first external
unlocking tool being detected within the predetermined perimeter of
the implantable medical device.
20. The one or more non-transitory computer-readable storage media
of claim 19, wherein the operations further comprise identifying a
second unlocking tool, and wherein communicating with the
implantable medical device includes establishing the radio
frequency communication with the implantable medical device
responsive to identifying the second unlocking tool is identified.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 16/709,728, filed Dec. 10, 2019, which claims
the benefit of and priority to French Application No. 1872671 filed
Dec. 11, 2018, both of which are incorporated herein by reference
in their entirety.
BACKGROUND
[0002] The present invention relates to a device, a system and a
method for remotely writing into the memory of an implantable
active medical device.
[0003] An active implantable medical device, for example an
implantable pacemaker or a cerebral neurostimulation system,
generally comprises a telemetry function allowing communication by
non-invasive means with other devices or monitors to transmit
information and data from one device to another. Examples of
telemetry functions comprise programming of the implantable device
to perform certain monitoring or therapeutic tasks, transmission of
physiological data acquired in real time by the implantable device
and/or updating the program or software of the implantable medical
device.
[0004] The telemetry communication between the active implantable
medical device and another external device can be performed
according to a first communication mode, near field telemetry or
inductive telemetry. This first mode of communication is based on
the inductive coupling between two coils positioned closely facing
each other by using the mutual inductance between these coils. This
first mode of communication requires an inductive telemetry housing
containing a coil and connected via an electrical wire to an
external monitor, which housing must be placed and held over the
coil of the active implantable medical device to allow
communication between both devices by inductance. As a result, the
mobility of the patient is reduced during data transfer because the
inductive telemetry is in short distance range, of the order of
five to ten centimeters, and then requires a close proximity
between the device implanted in the patient and the inductive
telemetry housing. In addition, inductive telemetry has a slow data
transfer rate of the order of several kilobits per second. This
transfer rate is not suitable for modern active implantable medical
devices, which may contain millions of bits of physiological data
of the patient.
[0005] For remote monitoring applications, the newest active
implantable medical devices use another type of long-range
telemetry communication mode, which comprises, for example,
wireless telemetry using a network connection (for example the
Internet or a telephone line), and telemetry systems using
far-field electromagnetic radiation. US 2004/0260363 A1 relates to
such long-range telemetry allowing an implantable device to
transmit data to a remote monitoring unit and to be programmed by a
clinician at a location remote from the patient. For example,
long-range telemetry allows clinicians from a hospital to monitor
and track patients who have remained at home, or even elsewhere in
the world. Long range telemetry thus provides more patient mobility
during data transfer, and also provides a higher data transfer
rate, which reduces download time.
[0006] Nevertheless, for confidentiality and security reasons and
in particular in case of hacking of the telemetry system, the use
of long-range telemetry is generally limited to downloading the
data from the active implantable medical device, for example to
perform remote monitoring, and is not applied to the modification
or software update of the implantable device, that is to say the
writing into the memory of the implantable medical device.
[0007] In order to counter the risk of hacking of long-range
telemetry between the implantable medical device of the patient and
the clinician's external device (for example a control unit), the
document US 2004/0260363 A1 cited above suggests to implement a
locking and authentication system based on short-range telemetry
using the static magnetic field of a magnet to allow remote access
to the implantable device and to encrypt long range telemetry
communications.
[0008] However, concerns about the safety of such a system remain
because of the direct access by long-range telemetry between the
implantable medical device and an external programming device.
[0009] US 2007/0135855 A1 relates to a portable programming device
capable of programming a plurality of implantable medical devices
jointly or independently, and which is configured to interact
simultaneously with a range of external devices, such as a server
or a computer. The portable programming device according to US
2007/0135855 A1 functions as a communication channel between the
implantable medical devices and an external device via the
interface of a network portal, in particular an internet network.
When the permission to access the implantable medical device is
issued, following the authentication of the identifiers recorded in
the portable programming device, downloading and processing data
via the portable programming device between each implantable
medical device and the external device are allowed.
[0010] Nevertheless, the portable programming device according to
US 2007/0135855 A1 is limited to clinical use, in particular for
large-scale use on several patients simultaneously, and is thus not
suitable for home use of a patient who is located away from a
medical center.
[0011] There is therefore in the field of implantable active
medical devices a need to improve the solutions that allow the
reprogramming and writing of the memory of such devices by
long-range telemetry, in particular by network connection, of a
patient being at home by a clinician operating in a medical center
several miles from the patient's home.
SUMMARY
[0012] Therefore, the object of the present invention is to provide
a system and method allowing secure operation of writing memory of
an implantable active medical device of a patient being several
kilometers away from the clinician performing the writing operation
of the memory of the implantable device.
[0013] The object of the present invention is achieved by a
communication system for enabling a writing operation in the memory
of an active implantable medical device. The communication system
comprises the active implantable medical device which comprises at
least one proximity sensor. The communication system further
comprise a remote non-implantable main writing device, an external
non-implantable intermediate proximity device which is configured
to receive instructions and write data transmitted via the remote
main writing device through a network connection, the intermediate
proximity device being configured to communicate wirelessly with
the implantable medical device, and a first non-implantable
external unlocking tool configured to transmit a detectable signal
by the proximity sensor when the first unlocking tool is located
within a predetermined perimeter of the medical device. The
intermediate proximity device is configured to write into the
memory of the implantable active medical device according to the
instructions transmitted via the remote main writing device in
response to a detection of the presence in the predetermined
perimeter of the first unlocking tool via the proximity sensor of
the active implantable medical device.
[0014] As a result, this system makes it possible to improve the
security of remote communication with an active implantable medical
device thanks to a first safety barrier established by the
intermediate device which prevents direct access from the writing
device to the implantable medical device by network connection; and
a second security barrier with the first unlocking tool that allows
access to the implanted medical device when it is located in a
perimeter in the immediate vicinity of the implantable medical
device. Thus, the writing operation can be done only on the
authorization given by the patient who must unlock the active
access to its implantable medical device by the use of the first
unlocking tool. This makes it possible to improve the security of
long-range telemetry by network connection and thus optimize the
writing of the memory of an implanted medical device by a writing
device of a clinician who is several kilometers away the home of
the implanted patient.
[0015] The present invention relating to a communication system can
be further improved by the following embodiments.
[0016] According to one embodiment, the system may further comprise
a second unlocking tool configured to allow radiofrequency
communication between the active implantable medical device and the
intermediate proximity device when the intermediate proximity
device has identified the second unlocking tool so that the
intermediate proximity device is configured to write into the
memory of the active implantable medical device according to the
instructions transmitted by the remote main writing device in
response to the identification of the second unlocking tool by the
intermediate proximity device. The security of the writing
operation can thus be further improved thanks to the second
unlocking tool that maximizes the number of safety barriers
allowing access to the implantable medical device.
[0017] According to one embodiment, the second unlocking tool can
comprise at least one password entered on the intermediate
proximity device, a biometric input received by the intermediate
proximity device, a magnetic card read via the intermediate
proximity device, a short distance wireless communication which
transmits a detectable signal via a proximity sensor of the
intermediate proximity device, a magnetic field detected by the
intermediate proximity device or a transmission received via a
peripheral port of the intermediate proximity device, in particular
a USB port. As a result, the second unlocking tool is a proximity
unlocking tool for use in the immediate vicinity of the implantable
medical device. The second unlocking tool is thus such that its
hacking is not possible via long range telemetry for example.
[0018] According to one embodiment, the intermediate proximity
device may be configured to provide at least one of a visual,
audible, or vibrating signal indicating that the writing operation
has to be performed. This signaling means makes it possible to
alert the patient that a writing operation is to be performed and
thus to maximize the chances that a rewriting request is detected
by the patient.
[0019] According to one embodiment, the intermediate proximity
device may be further configured to store the writing data
transmitted by the remote main writing device at least until the
operation is activated. As a result, the writing data is recorded
and kept for at least the time that the writing operation is
allowed. This avoids that the instructions and the writing data
provided by the clinician to the main writing device are lost while
waiting for the identification of the unlocking tool (s).
[0020] According to one embodiment, the first unlocking tool may be
a permanent magnet or an electromagnet whose static magnetic field
is detected by the proximity sensor of the active implantable
medical device. The first locking tool is thus easy to manufacture
and inexpensive.
[0021] According to one embodiment, the non-implantable
intermediate proximity device may be a Smartphone, a digital
tablet, a connected portable device, a computer, a home medical
equipment device or a home automation system.
[0022] Thus, the intermediate proximity device is, in particular, a
portable device which improves the mobility of the patient during
the writing operation from home.
[0023] In combination or alternatively, the intermediate proximity
device can be used for other purposes than that of the writing
operation, thereby reducing the number of devices in the home of a
patient.
[0024] According to one embodiment, the system may further comprise
a portable communication device, in particular to a mobile phone, a
tablet, a laptop or a connected watch to which the request for a
writing operation is sent via network connection by a message, an
SMS ("Short Message Service"), an email or a similar type of alert.
Thus, if the request sent to the intermediate proximity device has
not been detected by the patient, the sending the request to
another device that the patient is likely to keep close to or on
her or him increases the probability that the patient answers and
authorizes access to its implanted medical device by telemetry to
the clinician. Thus, the number of failed attempts for non-response
to the request of a writing operation by the clinician can be
reduced.
[0025] The embodiments may be combined to form more advantageous
alternative embodiments of the present invention.
[0026] The object of the present invention is also achieved by a
method for enabling a writing operation in the memory of an active
implantable medical device comprising the steps of sending a
network connection request to a wireless non-implantable
intermediate proximity device for a writing operation of the
implantable active medical device by a remote main writing device,
receiving via the intermediate proximity device instructions and
writing data sent via network connection by the remote main writing
device, placing a first non-implantable external unlocking tool
within a predetermined proximity perimeter of the active
implantable medical device to allow radiofrequency communication
between the intermediate proximity device and the active
implantable medical device, and writing said write data into the
memory of the active implantable medical device via the
intermediate proximity device.
[0027] This method allows improving the security of remote
communication with an active implantable medical device through a
first security barrier established by the intermediate device which
prevents direct access of the writing device to the implantable
medical device by network connection; and a second security barrier
with the first unlocking tool that allows access to the implanted
medical device via the intermediate communication device. In
addition, the writing operation can be done only on the request of
a clinician and the acceptance of this request by a patient who
must then allow access to his implantable medical device by the use
of the first and the second unlocking tools in the immediate
vicinity of the implantable medical device. The succession of these
steps makes it possible to further improve the security of
exchanges via network connection. Thus, improving the security of
long-range telemetry by network connection optimizes the writing of
the memory of an implanted medical device by a writing device of a
clinician who is several kilometers away the home of the implanted
patient.
[0028] The present invention relating to a method for enabling a
writing operation in the memory of an active implantable medical
device can be further improved through the following
embodiments.
[0029] According to one embodiment, the writing operation of the
active implantable medical device can be prevented when the first
unlocking tool is not detected by the active implantable medical
device, in particular when the distance between the first unlocking
tool and the active implantable medical device is larger than 15
centimeters, more particularly larger than 10 centimeters.
[0030] As a result, the first unlocking tool requires a very close
contact with the active implantable medical device, which may even
be in contact with the patient's skin, which implies that the
patient is aware of this unlocking step and from which he has
supposedly accepted the writing operation request. Hacking of this
unlocking operation is thus not possible from long range
telemetry.
[0031] According to one embodiment, for the method may further
comprise receiving, via the intermediate proximity device, the
request to authorize radiofrequency communication between the
intermediate proximity device and the active medical device
implantable by means of a second non-implantable external unlocking
tool. The security of the step of the writing operation can thus be
further improved thanks to the second unlocking tool that maximizes
the number of safety barriers allowing access to the implantable
medical device.
[0032] According to one embodiment, the second unlocking tool may
comprise at least one password entered on the intermediate
communication device, a biometric input received the intermediate
communication device, a magnetic card read by the intermediate
communication device, a short-distance wireless communication which
transmits a detectable signal via a proximity sensor of the
intermediate communication device, a magnetic field detected by the
non-implantable communication device or a transmission received via
a peripheral port of the intermediate communication device, in
particular a USB port. The use of a second unlocking tool makes it
possible to further improve the security of the network connection
communication by multiplying the validation requests to authorize
the writing operation into the memory of the implantable medical
device.
[0033] According to one embodiment, the radiofrequency
communication between the active implantable medical device and the
intermediate communication device can be realized when there is a
distance of less than 10 meters between the active implantable
medical device and the intermediate communication proximity
device.
[0034] The distances allowing the communication between the active
implantable medical device and the intermediate communication
device are thus adapted so that a patient can perform the writing
operation at home.
[0035] According to one embodiment, the first unlocking tool can
emit a signal to the active implantable medical device that comes
from an electromagnetic field or a static magnetic field or an
inductive field. The first locking tool is thus easy to manufacture
and inexpensive.
[0036] According to one embodiment, the request for the writing
operation can be signaled by a signaling means of the intermediate
proximity device, which emits at least one of a visual, audible, or
vibrating signal indicating that a writing operation must to be
carried out. This signaling means makes it possible to alert the
patient that a writing operation is to be performed and thus to
maximize the chances of a rewriting request being detected by the
patient.
[0037] According to one embodiment, the request for a writing
operation can also be sent via a network connection to a portable
communication device, in particular to a mobile phone, a tablet, a
laptop and/or a watch connected via a message, an SMS ("Short
Message Service"), an email or any similar type of alert. Thus, if
the request sent to the intermediate proximity device has not been
detected by the patient, the sending of the request to another
device that the patient is likely to keep close to or on her or him
increases the probability that the patient answers and authorizes
access to its implanted medical device by telemetry to the
clinician. Thus, the number of failed attempts for non-response to
the request for a writing operation by the clinician can be
decreased.
[0038] According to one embodiment, the writing data is stored by a
storage means of the intermediate proximity device at least until
the authorization of a radio frequency communication between the
intermediate proximity device and the implantable active medical
device. As a result, the writing data is recorded and kept for at
least the time that the writing operation is allowed. This thus
avoids that the instructions and the writing data provided by the
clinician to the main writing device in the previous steps a) and
b) are lost while waiting for the identification of the unlocking
tool(s).
[0039] The embodiments may be combined to form more advantageous
alternative embodiments of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] The invention and its advantages will be explained in more
detail in the following by means of preferred embodiments and
relying in particular on the following accompanying figures,
wherein:
[0041] FIG. 1 schematically shows a communication system for
enabling a writing operation in the memory of an active implantable
medical device according to a first embodiment of the
invention;
[0042] FIG. 2 schematically represents a communication system for
enabling a writing operation in the memory of an active implantable
medical device according to a second embodiment of the
invention;
[0043] FIG. 3 represents a flowchart of the communication method
for enabling a writing operation in the memory of an implantable
active medical device according to the first embodiment of the
invention;
[0044] FIG. 4 represents a flowchart of the communication method
for enabling a writing operation in the memory of an implantable
active medical device according to the second embodiment of the
invention.
DETAILED DESCRIPTION
[0045] The invention will now be described in more detail using
advantageous embodiments in an exemplary method and with reference
to the drawings. The described embodiments are merely possible
configurations and it should be borne in mind that the individual
characteristics as described above can be provided independently of
one another or can be omitted altogether during the implementation
of the present invention.
[0046] FIG. 1 schematically illustrates the communication system 1
to enable a writing operation of an active implantable medical
device 100 according to a first embodiment of the invention.
[0047] The implantable medical device 100, such as an implantable
pacemaker or a cerebral neurostimulation system, is configured to
be implanted in a patient. The implantable medical device 100
comprises, inter alia, a proximity sensor 103 and a memory 105.
Updates of the implantable medical device 100, as well as updates
of the implantable medical device software 100, may be required
during the life of the patient. In order to prevent the patient
from having to go to a hospital center 203 for a clinician to
perform a writing operation into the memory 105 of the implantable
medical device 100, the communication system 1 is configured to
allow a writing operation to be performed into the active
implantable medical device 100 from the patient's home 107 by a
clinician device 200 located in a hospital center 203 such that the
distance D between the active implantable medical device 100 and
the clinician device 200 is of several kilometers. To do this, the
communication system 1 uses a long range telemetry function.
[0048] In order to secure the long range telemetry communication,
the communication system 1 also comprises a wireless external
non-implantable intermediate proximity device 110. The intermediate
proximity device 110 is configured for radiofrequency communication
with the implantable medical device 100 at a distance d1 from the
implantable medical device 100, such that d1 is less than 10
meters. The intermediate device proximity 110 may be a Smartphone,
a digital tablet, a connected portable device, a computer, a home
medical equipment device or a home automation system. The
intermediate proximity device 110 is therefore suitable for use in
the home 107 of a patient. The intermediate proximity device 110 is
configured to acquire data transmitted by a clinician device 200,
also referred to hereinafter as the main remote writing device 200.
The intermediate proximity device 110 is configured to acquire data
205 transmitted by the main writing device 200 via a network
connection 300, in particular via a wired or wireless Internet
connection, or a telephone line. The intermediate proximity device
110 comprises storage means 113 for storing the writing data 205,
at least until authorization to access the implantable medical
device 100. In addition, the intermediate proximity device 110 is
also configured to receive data from the radiofrequency implantable
medical device 100 and transmit it to the main device 200 remotely
over a network connection. Thus, the system 1 is configured both
for a writing operation into the memory 105 of the implantable
medical device 100 but also for the reception of data from the
implanted medical device 100 such as for example physiological data
acquired by the implanted device 100. This data can be transmitted
by the intermediate proximity device 110 to the remote main device
200 which can, for example, adapt the writing operation of the
memory 105 of the implantable medical device 100.
[0049] According to a preferred embodiment, the main writing device
200 has access to a website, on which a clinician can enter the
writing data 205 and such that the intermediate proximity device
110 also has access to this website via an Internet connection and
can therefore acquire said writing data 205. According to another
embodiment, other types of long-range network connection can be
established between the intermediate proximity device 110 and the
main writing device 200. Network connection 300 allows
communication between the intermediate device proximity 110 and the
main writing device 200 over a distance of several kilometers, in
particular on the distance D between the home 107 of a patient and
a hospital center 203 where the clinician device 200 is located.
Thus, the intermediate proximity device 110 connects the
implantable medical device 100 and the main writing device 200
without, however, direct communication via the network connection
between the main writing device 200 and the implantable medical
device 100 to reduce the risk of hacking of the implantable medical
device 100.
[0050] In addition, in order to alert the patient that a clinician
wishes to write or update the software of his implantable medical
device 100, the intermediate device proximity 110 of the patient
comprises a signaling means which sends a notification, for example
in the form of an alert message and/or an audible and/or visual
and/or vibrating signal.
[0051] To further improve the security of the network connection
300, the communication system 1 comprises a first non-implantable
external unlocking tool 120, distinct from the non-implantable
wireless intermediate proximity device 110 which is configured to
send a detectable signal 121 by the proximity sensor 103 of the
implantable medical device 100. According to the embodiment
illustrated in FIG. 1, the first unlocking tool 120 is a permanent
magnet or an electromagnet whose static magnetic field is detected
by the proximity sensor 103 of the active implantable medical
device 100. In another embodiment, the first unlocking tool 120 is
configured to send a signal 121 from an electromagnetic field, an
inductive field, or a human body communication system. When the
first unlocking tool 120 is located within a predetermined
perimeter, i.e. less than a distance d2 from the medical device
100; such that the distance d2 is less than 15 centimeters, in
particular less than 10 centimeters; the presence of the first
unlocking tool 120 is detected by the implantable medical device
100. The detection of the presence of the first unlocking tool 120
in the predetermined perimeter allows access of the active
implantable medical device 100 to the intermediate proximity device
110. Accordingly, the radio frequency communication 130 between the
active implantable medical device 100 and the intermediate
proximity device 110 is enabled. The authorization of the
radiofrequency communication 130 therefore requires that a patient
positions the first unlocking tool 120 close enough to the
implantable medical device 100 to unlock it, that is to say less
than 15 cm from the implantable medical device 100.
[0052] FIG. 2 schematically illustrates a communication system 2
for enabling a writing operation of an active implantable medical
device 100 according to a second embodiment of the invention.
Elements with the same numerical references already used for the
description of FIG. 1 will not be described again in detail, and
reference is made to their descriptions above.
[0053] The communication system 2 comprises the active medical
implantable device 100, the intermediate proximity device 110, the
main writing device 200 and the first unlocking tool 120 as
described above for the communication system 1.
[0054] In order to further improve the security of the long-range
telemetry writing operation, the communication system 2 further
comprises a second unlocking tool 140 configured to unlock the
intermediate proximity device 110 and thus to allow radio frequency
communication between the active implantable medical device 100 and
the intermediate proximity device 110.
[0055] According to the second embodiment illustrated in FIG. 2,
the second unlocking tool 140 is a magnetic card 141 configured to
be scanned and read by the intermediate proximity device 110.
According to other embodiments, the second unlocking tool 140 may
also comprise at least one password to enter the intermediate
proximity device 110, a biometric input received by the
intermediate proximity device 110, a short-distance wireless
communication which transmits a signal detectable by a proximity
sensor of the intermediate proximity device 110, a magnetic field
detected by the intermediate proximity device 110 or a transmission
received via a peripheral port of the intermediate proximity device
110, such as a USB port for example.
[0056] Thus, according to the second embodiment, the rewriting
authorization in the memory 105 of the active implantable medical
device 100 in the system 2 requires that a patient positions the
first unlocking tool 120 close enough, that is, say less than 15
cm, from its implantable medical device 100 to unlock it, and that
he or she scans his or her personal magnetic card 141 so that the
personal magnetic card 141 is read and identified by the
intermediate proximity device 110. Therefore, in the second
embodiment, the system 2 comprises two proximity unlocking means
120, 140 which are configured to be operated in close proximity to
the patient (less than 15 centimeters for the first tool 120)
and/or by the patient himself. As a result, these unlocking
proximity tools 120, 140 enable to improve and secure a writing
operation in the memory 105 of the implantable medical device 100
by long-range telemetry.
[0057] This writing operation is signaled to the patient by the
signaling means 115 of the intermediate proximity device 110 which
issues a notification, for example in the form of an alert message
and/or an audible, and/or a visual, and/or a vibrating signal. In
addition, according to the second embodiment, a notification can
also be sent in parallel to a portable device of the patient 109
such as his mobile phone 109 or a connected watch, to ensure that
he is informed of the request for the writing operation, even when
he does not have the intermediate proximity device 110 directly at
hand. The notification may be at least one visual signal, an
audible signal, a vibration, a written message, a voice message at
least on the intermediate proximity device 110. The portable device
109 of the patient may receive in parallel a notification of the
same or of a different category from that sent to the intermediate
proximity device 110.
[0058] The operation of the communication system 1 will be
explained in the following via the description of the flowchart 500
of FIG. 3. The elements with the same numeral references already
used for the description of FIG. 1 will not be described again in
detail, and reference is made to their descriptions above.
[0059] When an update, a rewriting of the memory 105, an adjustment
or a reprogramming of the software of the implantable medical
device 100 of the patient is required, a clinician enters a request
in the clinician device 200 to notify the patient of a writing
operation request. Therefore, in the first step 501 of the method
500 illustrated in FIG. 3, a request is sent from the clinician
device 200 via network connection, in particular via an Internet
connection, to the patient's intermediate proximity device 110. The
reception of this request at the intermediate proximity device 110
is signaled to the patient by the signaling means 115 of the
intermediate proximity device 110, which emits an audible
notification, a flashing light, a message and/or a vibration.
[0060] The first step 501 is followed by the step 502 of
acquisition of the writing data 205 by the intermediate proximity
device 110. The writing data 205 are input to the main writing
device 200 by a clinician. This writing data 205 is transmitted by
long-range telemetry to the intermediate proximity device 110. In
particular, this writing data 205 is entered on a website and
transmitted via an Internet connection to the intermediate
proximity device 110 which has also access to this website in order
to acquire the writing data 205. The intermediate proximity device
110 comprises a storage means 113 for storing the writing data 205,
at least until authorized to access to the implantable medical
device 100, i.e., until rewriting in the memory 105 of the
implantable medical device 100 has been enabled by the detection of
the first unlocking tool 120.
[0061] Indeed, the operation of writing into the memory 105 of the
implantable medical device 100 requires allowing the intermediate
proximity device 110 to transmit to and receive data from the
implantable medical device 100.
[0062] Therefore, in a second step 503 of the method 500
illustrated in FIG. 3, the first unlocking tool 120 is required to
be placed within the predetermined proximity perimeter of the
active implantable medical device 100, that is to say less than 10
centimeters, so that the proximity sensor 103 of the implantable
medical device 100 detects the presence of the first unlocking tool
120. The detection of the first unlocking tool 120 allows a
radiofrequency communication 130 to be enabled between the
intermediate proximity device 110 and the active implantable
medical device 100. The non-detection of the first unlocking tool
120 by the proximity sensor of the implantable medical device 130
prevents a writing operation of the memory 105 of the implantable
medical device 100.
[0063] If the unlocking conditions are enabled in step 503, access
to the implantable medical device 100 is allowed for the
intermediate proximity device 110 for a predetermined period of
time. After this predetermined period of time, access to the
implantable medical device 100 is locked such that the intermediate
proximity device 110 or any other telemetry device can no longer
access the implantable medical device 100. According to an
advantageous embodiment, the predetermined period of time starts
upon receipt by the intermediate proximity device 110 of the
request for the writing operation, i.e., at step 501.
[0064] In step 504 of method 500, the writing data 205 acquired by
the intermediate proximity device 110 is transmitted to the active
implantable medical device 100. This results in a writing operation
in the memory 105 remote from the implantable medical device 100
according to data 205 entered by the clinician.
[0065] When writing to the memory 105 of the implantable medical
device 100 or any other reprogramming, updating or adjusting
operation of the implantable medical device 100, is successfully
performed, the implantable medical device 100 sends an
end-of-process notification to the intermediate proximity device
110 that informs the patient that he can remove the first unlocking
tool 120 and that transmits the end-of-process notification to the
clinician device 200. The clinician device 200, and therefore the
clinician himself, is thus informed of the success or failure of
the rewriting operation. According to an advantageous embodiment, a
predetermined duration of time must be respected between each
attempt to rewrite into the implantable medical device 100.
[0066] Thus, the method 500 makes it possible to improve the
security of the remote communication with the active implantable
medical device 100 by means of a first security barrier established
by the intermediate proximity device 110 which prevents direct
access from the writing device 200 to the implantable medical
device 100 via network connection; and a second safety barrier with
the first short-range proximity unlocking tool 120 which allows
access to the implanted medical device 100 via the intermediate
proximity device 110.
[0067] Thus, the writing operation can only be done on the request
of the clinician and the acceptance of this request by the patient
who must then allow access to his implantable medical device 100 by
the use of the first unlocking tool 120 In the immediate vicinity
of its implantable medical device 100. The succession of these
steps makes it possible to further improve the security of
exchanges by network connection.
[0068] The operation of the communication system 2 will be
explained in the following via the description of the flowchart 600
of FIG. 4. The elements with the same numerical references already
used for the description of FIGS. 1, 2 and 3 will not be described
again in detail, and reference is made to their descriptions
above.
[0069] According to the method of the second embodiment, when
updating, rewriting the memory 105, adjusting or reprogramming the
software of the implantable medical device 100 of the patient is
required, a clinician enters a request in the clinician device 200
to notify the patient of a writing operation request. Therefore, in
the first step 601 of the method 600 illustrated in FIG. 4, a
request is sent from the clinician device via network connection,
in particular via an Internet connection, to the patient's
intermediate proximity device 110. The reception of this request at
the intermediate proximity device 110 is signaled to the patient by
the signaling means 115 of the intermediate proximity device 110
which emits an audible notification, a flashing light, a message
and/or a vibration. In parallel, according to the second
embodiment, a notification, for example a message, an SMS ("Short
Message Service"), an email or other, can also be sent to a
portable device of the patient 109 such as on his mobile phone 109
or his connected watch. The notification tells the patient the
request for a long-range telemetry rewriting operation. The writing
operation of the memory 105 of the implantable medical device 100
requires allowing the intermediate proximity device 110 to transmit
and receive data to the implantable medical device 100.
[0070] The first step 601 is followed by the step 602 of acquiring
the writing data 205 by the intermediate proximity device 110. The
writing data 205 are input to the main writing device 200 by a
clinician. This writing data 205 is transmitted by long-range
telemetry to the intermediate proximity device 110. In particular,
this writing data 205 is entered on a website and transmitted via
an Internet connection to the intermediate proximity device 110
which has also access to this web site to acquire the writing data
205. The writing data 205 is stored by the storage means 113 of the
intermediate proximity device 110 at least until authorized to
access the implantable medical device 100, i.e. until the rewriting
in the memory 105 of the implantable medical device 100 is enabled
by the detection of the unlocking tools 120 and 140. Indeed, the
operation of writing the memory 105 of the implantable medical
device 100 requires allowing the intermediate proximity device 110
to transmit and re receive data from the implantable medical device
100.
[0071] Therefore, in a third step 603 of method 600, the
authorization of the radio frequency communication 130 between the
intermediate proximity device 110 and the active implantable
medical device 100 must be authorized by means of the second
non-implantable external unlocking tool 140. The non-validation of
the second unlocking tool 140 by the implantable medical active
device 100 prevents a writing operation in the memory 105 of the
implantable medical device 100.
[0072] Then, during a fourth step 604 of the method 600 illustrated
in FIG. 4, the first unlocking tool 120 is requested to be placed
in the predetermined proximity perimeter of the implantable active
medical device 100, that is to say to less than 10 centimeters, so
that the proximity sensor 103 of the implantable medical device 100
detects the presence of the first locking tool 103. The detection
of the first unlocking tool 103 allows authorizing a radio
frequency communication 130 between the intermediate device 110 and
the implantable active medical device 100. The non-detection of the
first unlocking tool 120 by the proximity sensor of the implantable
medical device 130 prevents a writing operation of the memory 105
of the implantable medical device 100.
[0073] In a variant which is not illustrated in FIG. 4, step 603
can be performed after step 604. In another variant, steps 603 and
604 can be performed simultaneously.
[0074] If the unlocking conditions are enabled in steps 603 and
604, access to the implantable medical device 100 is allowed for
the intermediate proximity device 110 for a predetermined period of
time. After this predetermined period of time, access to the
implantable medical device 100 is locked such that the intermediate
proximity device 110 or any other telemetry device can no longer
access the implantable medical device 100. Advantageously, the
predetermined period of time starts upon reception by the
intermediate proximity device 110 of the request for the writing
operation, i.e. step 601.
[0075] In step 605 of method 600, the writing data 205 acquired by
the intermediate proximity device 110 is transmitted to the active
implantable medical device 100. This results in a writing operation
in the memory 105 remote from the implantable medical device 100
according to the data 205 entered by the clinician.
[0076] When writing to the memory 105 of the implantable medical
device 100 or any other reprogramming, updating or adjusting
operation of the implantable medical device 100, is successfully
performed, the implantable medical device 100 sends an
end-of-process notification to the intermediate proximity device
110 that informs the patient that it can remove the unlocking tools
120 and 140 and that transmits the end-of-process notification to
the clinician device 200. The clinician device 200, and thus the
clinician himself or herself, is thus informed of the success or
failure of the rewriting operation. According to an advantageous
embodiment, a predetermined period of time must be respected
between each attempt of rewriting operation of the implantable
medical device 100.
[0077] Thus, the method 600 makes it possible to improve the
security of the remote communication with the implantable active
medical device 100 by means of a first security barrier established
by the intermediate proximity device 110 which prevents direct
access from the writing device 200 to the implantable medical
device 100 via network connection; and a second safety barrier by
the first short range unlocking tool 120 and the second unlocking
tool 140 which allow access to the implanted medical device 100 via
the intermediate proximity device 110. Thus, the writing operation
can be done only on the request of the clinician and the acceptance
of this request by the patient who must then allow access to his
implantable medical device 100 by the use of the first 120 and the
second unlocking tool 140. The succession of these steps makes it
possible to further improve the security of exchanges by network
connection.
[0078] The systems 1 and 2 and the methods 500 and 600 of the
present invention thus make it possible to improve the security of
the long range telemetry by network connection and thus to optimize
the writing in the memory 105 of the implanted medical device 100
by a writing device 200 of a clinician who is several kilometers
away from the home of the implanted patient.
[0079] The described embodiments are merely possible configurations
and it should be borne in mind that the individual features of the
different embodiments may be combined with each other or provided
independently of one another.
* * * * *